BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTELON CMC SPACER

    MDR report key: 1982664 · Received February 2, 2011

    Report

    Report Number
    3004878714-2011-00013
    Event Type
    Injury
    Date Received
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    ARTIMPLANT AB
    Product Code
    KYI
    PMA / PMN Number
    K040070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTATION TOOK PLACE BETWEEN (B)(6) 2006 AND (B)(6) 2007. THE IFU AT THAT TIME RECOMMENDED THAT THE CORTICAL BONE ON TRAPEZIUM SHOULD BE REMOVED. ACCORDING TO THE X-RAY PICTURES IN THE ARTICLE THIS WAS DONE IN ALL THREE CASES. AS A CONSEQUENCE THE FIXATION OF THE SCREW IN TRAPEZIUM WAS INADEQUATE, THE SCREW WAS ONLY FIXATED AT THE TIP. THE MOVEMENT OF THE SCREW CAUSED PAIN. IN OTHER CASES FROM THAT TIME REMOVAL OF JUST THE SCREW GAVE PAIN RELIEF WITHIN A WEEK. THE IFU WAS CHANGED IN Q3, 2007. PERSISTENT PAIN PROBABLY CAUSED BY POOR FIXATION OF THE SCREW IN TRAPEZIUM DUE TO REMOVAL OF CORTICAL BONE. (B)(4).

    Description of Event or Problem · 1

    (B)(6) REPORTED 3 CASES OF EXPLANATIONS OF CMC SPACER DUE TO PAIN (B)(4). ALL THREE PTS UNDERWENT A TENDON INTERPOSITION SURGERY AND ALL PTS REPORTED IMPROVEMENT IN SYMPTOMS. THE SPACER WAS WELL INTEGRATED. THE AUTHORS CLAIM A FOREIGN BODY REACTION TOWARD THE SPACER MATERIAL. PT 2 WAS EXPLANTED 9 MONTHS POST-OP. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTELON CMC SPACER SPACER KYI ARTIMPLANT AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other